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U.S. Department of Health and Human Services

Class 2 Device Recall BV243QA 3LUMEN EXTRACTION BALLOON V

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  Class 2 Device Recall BV243QA 3LUMEN EXTRACTION BALLOON V see related information
Date Initiated by Firm January 04, 2021
Create Date February 05, 2021
Recall Status1 Open3, Classified
Recall Number Z-0967-2021
Recall Event ID 87074
510(K)Number K091495  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Code Information 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV
Recalling Firm/
Manufacturer
Aomori Olympus Co., Ltd.
2 Chome 248-1
Okkonoki
Kuroishi Japan
For Additional Information Contact Laura Storms
484-8965688
Manufacturer Reason
for Recall
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
FDA Determined
Cause 2
Under Investigation by firm
Action On January 4, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the identified list of Endo-therapy devices may have a defective seal which may compromise the sterility of the product. Customers were asked to take the following actions: 1. Immediately assess any product you have in stock to identify endotherapy products with affected lot numbers listed in the recall letter. Cease use of product and quarantine any affected product. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit or replacement to your facility for any returned product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0391 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Quantity in Commerce 7,400,000 (global); 260,395 (US)
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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